How do they match: Regulatory Affairs Specialists

  • Compile and maintain regulatory documentation databases or systems.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.

  • Analyze data to identify or resolve operational problems.
  • Maintain data in information systems or databases.
  • Train personnel in organizational or compliance procedures.